Manager Medical Writing Job at Meet in New Hampshire

Position Overview:

We are seeking a Manager in Medical Writing to oversee the development of clinical regulatory documentation supporting drug development and regulatory filings. This role will focus on writing, revising, and managing high-quality materials while ensuring compliance with regulatory standards for submissions. The ideal candidate will have experience in regulatory submissions, including NDA, BLA, IND, CTA, and clinical document writing such as IB, CRS, and briefing books. The position requires candidates to be located in the Eastern or Central Time Zone.

Core Responsibilities:

• Lead the creation and revision of clinical regulatory documents, including submission summaries and key materials for drug development and regulatory submissions.
• Ensure all documents are thorough, precise, and comply with global regulatory guidelines and best practices, focusing on NDA, BLA, IND, and CTA submissions.
• Manage internal teams, contingent workers, and vendors, providing strategic direction to ensure efficient development of regulatory documents.
• Contribute to the creation of document templates and process improvements to enhance document quality and operational efficiency.
• Collaborate closely with cross-functional teams to ensure regulatory documentation aligns with submission requirements and global regulatory standards.

Required Qualifications:

• A PhD, PharmD, or Master’s degree in Life Sciences or a closely related field.
• A PhD/PharmD with 2+ years of experience or a Master’s with 4+ years of experience in regulatory medical writing.
• Proven expertise in regulatory writing, with experience in global submissions (NDA, BLA, IND, CTA) and clinical document writing (IB, CRS, briefing books).
• Proficiency in Microsoft Word and document preparation tools in electronic formats.
• Strong understanding of regulatory requirements and best practices for global submissions.
• Must be located in the Eastern or Central Time Zone.

This position does not offer work visa sponsorship.